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Statistical Considerations










          • Enrollment of 1050 patients was planned; 1069 patients were randomized





          • This final PFS analysis and interim OS analysis were based on a 28 August 2020 data



              cutoff date (median follow-up: 27 months), at ~388 PFS events for 90% power with


              2-sided α = 0.045






          • The observed number of final PFS events:


                 • 365 for LEN + PEMBRO versus SUN


                 • 396 for LEN + EVE versus SUN





          • PFS and OS differences between LEN + PEMBRO versus SUN, and LEN + EVE versus SUN,


              were evaluated using a stratified log-rank test
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